MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA AF125 ARTERIAL FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Catalog Number ZZ*AF125XA

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional- requested, not provided.Occupation- requested, not provided.Name and address- requested, not provided.Phone number- requested, not provided.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that there was a "pinhole leak on the outflow of the filter" during prime of the capiox arterial filter.The product was changed out and the surgery was completed successfully with no delays, and no blood loss or other patient complications reported.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection with the unaided eye and a magnifier revealed no damage or other external abnormality that could lead to a leak was observed.The tubes had been connected to the blood inlet and outlet, secured with tie-bands, and cut near the connections.After filling the product with colored normal saline, the blood outlet side was blocked and pressure of 152 kpa was applied into the blood channel from the blood inlet side to check for leaks, and no leaks were found.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.It was likely that the connections between the arterial filter and the circuit (blood inlet, blood outlet, and vent port) had loosened, possibly causing a leak path.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: AF125 ARTERIAL FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11893008
• MDR Text Key: 261942064
• Report Number: 9681834-2021-00096
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K052205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: ZZ*AF125XA
• Device Lot Number: 200325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1